Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management

Diabetes Clinical Trial

Official title:

Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391585
• Other study ID #: R24HS019453-01PRM
• Status: Completed
• Phase: N/A
• First received: July 8, 2011
• Last updated: February 10, 2014
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. The investigators will also see if they come in for lab tests when prompted by text message. Also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.

Description:

Patients will be sent text messages through a software interface, the Patient Relationship Manager (PRM). A registered nurse will also use PRM to receive incoming responses. Tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. This intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize PRM to better manage their diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75 years

• diabetes

• own a cell phone

• 2 primary care visits in last year

• English or Spanish speaking

Exclusion Criteria:

• End-stage disease with estimate of less than 6 months to live

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias

Intervention

Other:
• Text Message prompts
In this single armed intervention, patients will receive text message prompts

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate to home monitoring prompts	resonse rate to blood pressure, blood sugar, and step count prompts	4 months	No
Secondary	response rate to prompt for lab text by text message	response rate to prompt for lab text by text message	4 months	No
Secondary	response to barrier questions for non-adherence	We will analyze the responses to text message prompts in patients late for picking up medications.	4 months	No